News & Events Tight focus not a trial for CRO firm

Tight focus not a trial for CRO firm

December 15, 2006

Tight focus not a trial for CRO firm

CTI finds niche keeps it profitable in competitive field

CINCINNATI BUSINESS COURIER - DECMEBER 15, 2006

by James Ritchie

CTI Clinical Trial & Consulting Services gets the job about two-thirds of the time when it responds to requests for proposals.

It works with companies ranging in size from a couple of employees to pharmaceutical industry giants such as Pfizer Inc., GlaxoSmithKline Inc. and Roche. The company's CEO, Tim Schroeder, said CTI's careful cultivation of a relatively small market segment makes it a strong choice for any work it pursues.

"If you stay in narrow circles and do a good job, you're probably going to have a lot of success," he said.

The privately held Blue Ash firm designs and runs clinical trials and provides other consulting services that clients hope will help them win U.S. Food and Drug Administration approval and, eventually, market share for their product candidates.

It sticks to a handful of clinical areas: transplant, infectious disease, end-stage organ disease, hematology and immunology. The company's expertise has resulted in a stable of about 30 clients, about two thirds of which are U.S.-based and the rest of which are foreign.

Schroeder said he didn't know of another clinical research organization operating in exactly the same niche, though there's plenty of competition. Some, such as the much larger Cincinnati-based Kendle Inc., which is publicly traded, are essentially generalists and may take on work in the same areas.

"If someone comes to us and says, 'We have a psychiatry project,' for example, we tell them, 'You ought to hire somebody else,'" he said.

In March, the company, which leases 40,000 square feet in Blue Ash's Northmark II building and has a suburban Philadelphia office, had about 65 employees. Schroeder wouldn't release a current figure but said he's been adding one to two employees per month for the last five years.

He would not divulge financials, but said the company, formed in 1999, has been profitable since its first year.

CTI's revenues should grow 30 percent in 2007, Schroeder said, a rate similar to the past few years.

The former University of Cincinnati professor started the firm with money from exercised stock options after leaving SangStat Medical Corp. in California. He's always operated it with no debt.

The company's work can be make-or-break for its clients, especially small firms whose futures may be tied to a single technology.

"They kind of use us as their right hand" sometimes, said Lynn Fallon, executive vice president of CTI.

The firm is helping Martin Rosendale to develop the U.S. business of Core Dynamics, which started in Israel.

In about three months the company will start human trials of one application of a technology to store reserves of biological material. Eventually the technology could lead to women who are being treated for cancer being able to have their ovaries removed, stored and later reimplanted.

CTI has consulted with Core Dynamics, which has four employees in the United States and about 30 in Israel, on regulatory pathways, even attending FDA meetings with the firm.

"How the FDA would regulate something like that; it's all new ground," said Rosendale, CEO of Core Dynamics Inc., based in Maryland.

That meant that having the right expertise in a consultant was crucial. Rosendale already knew Schroeder from a previous job, and he knew CTI had the focus and contacts he needed.

CTI also has worked with firms from countries including Denmark, Japan, Canada, Germany, Israel, France and the United Kingdom. Schroeder believes the work could eventually lead to some of those companies opening offices in Cincinnati.
One client, Danish firm LifeCycle Pharma A/S, recently raised $82 million in an initial public offering and now trades on the Copenhagen Stock Exchange.
Schroeder's firm worked with the company, which has fewer than 40 employees, on one application of its core technology to enhance release and absorption of drugs. LifeCycle expects to start human trials next month, he said.

CTI Snapshot

Name: CTI Clinical Trial & Consulting Services

Address: 10123 Alliance Road, Blue Ash, 45242

Phone: (513) 598-9290 Web address: www.ctifacts.com

President: Tim Schroeder

Description: Designs and runs clinical drug trials and provides consulting in areas that include transplant, infectious diseases, end-stage organ disease, hematology and immunology.

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